Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of ventilations with VTe between 4-8ml/kg
研究概览
简要总结
This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.
详细描述
The study was conducted at the Neonatal Intensive Care Unit and the delivery room at the Division of Neonatology, at the Medical University of Vienna.
We aimed to record ventilation parameters (tidal volume, mask leak, ventilation rate, PIP, PEEP) using a CE-certified Respiratory Function Monitor (Neo100, Monivent AB, Gothenburg, Sweden), which was either hidden or visible to the provider responsible for the airway (airway provider), during ventilations on term and preterm patients at the NICU and the delivery room.
The investigators aimed to determine the quality of ventilations performed by healthcare professionals depending on RFM visibility. Analysis occurred, determining whether observing the data displayed on the RFM during PPV of preterm and newborn infants lead to adjustments in applied pressure and an increase in the proportion of inflations performed within a predefined range of 4-8 ml/kg for VTe.
The investigators hypothesized that using a RFM with numeric and graphical display of values during positive pressure ventilation of infants will lead to i) more frequent recognition and correction of tidal volumes outside the predefined range and ii) reduction of mask leak.
This knowledge gain may improve future training using a RFM to improve the quality of ventilations and, thereby, patient safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at the Neonatal Intensive Care Unit (NICU) and in the delivery room who receive positive pressure ventilation
- •Written consent from parents or legal guardians of patients
- •Preterm and term infants (male and female, any gestational age)
排除标准
- •Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study
结局指标
主要结局
Proportion of ventilations with VTe between 4-8ml/kg
时间窗: through study completion, an average of 1 year
percentage of ventilations within range divided through all ventilations performed, for each participant
次要结局
- Mean value for peak inflation pressure(through study completion, an average of 1 year)
- Comparison of elective versus delivery room interventions(through study completion, an average of 1 year)
- Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)(through study completion, an average of 1 year)
- Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)(through study completion, an average of 1 year)
- Mean value for ventilation rate (defined as ventilations per minute)(through study completion, an average of 1 year)
- Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations(through study completion, an average of 1 year)
- Comparison of ventilations via face mask vs. endotracheal tube(through study completion, an average of 1 year)
- Outcome data and adverse events(through study completion, an average of 1 year)
- Comparison of fellows vs. consultants(through study completion, an average of 1 year)
- Comparison of sef-inflating-bag vs. neo-T(through study completion, an average of 1 year)
研究者
Michael Wagner
Principal Investigator
Medical University of Vienna